Acera Surgical’s Restrata Studied for the Treatment of Venous Leg Ulcers

February 10, 2022—Acera Surgical, Inc., a developer of fully synthetic materials for regenerative medical applications, announced commencement of patient enrollment in a clinical study evaluating the company’s Restrata for the treatment of nonhealing venous leg ulcers (VLUs).

According to the company, the study is a prospective, randomized, multicenter trial comparing wound closure with Restrata, a fully synthetic hybrid-scale fiber matrix, versus a living cellular skin substitute in the treatment of VLUs. The primary outcome measurement of the trial will be the number of study participants with 100% epithelialization of the wound within a 16-week period.

The study’s lead investigator is William Marston, MD. Dr. Marston is the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine in Chapel Hill, North Carolina.

Dr. Bradley P. Abicht, DPM, who is Section Chair of Podiatry at Gundersen Health System in La Crosse, Wisconsin, commented in Acera’s press release, “Our team is excited to participate in this head-to-head, prospective clinical trial to further develop Restrata as a novel approach for difficult-to-treat VLUs. Our practice has been pleased with the outcomes of Restrata when used to treat very complex lower extremity wounds of varying etiology.”

John Park, MD, Vascular Surgeon at Nebraska Methodist Hospital in Omaha, Nebraska, added, “I am very delighted to be part of this trial and to enroll our center’s first patient as it will provide important evidence comparing the efficacy of Restrata versus a leading competitor for the treatment of VLUs. I applaud Acera Surgical for conducting this study since it is the first of its kind in a VLU population.”

Acera Surgical stated that Restrata is indicated for use in a variety of wounds, including surgical wounds, trauma wounds, and chronic wounds such as diabetic foot ulcers and VLUs. Restrata is manufactured with synthetic bioresorbable polymers and possesses a fibrous structure with high porosity.

The product architecture, which is similar to native extracellular matrix, allows for cell ingress and retention, as well as neovascularization of the newly forming tissue without the need for added growth factors. As the wound healing process progresses, Restrata completely degrades via hydrolysis, leaving native tissue in its place, noted the company.